Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Allergy Therapeutics has submitted 10 marketing authorisation applications (MAAs) to the Paul Ehrlich Institute, the Regulatory Authority for biological products in Germany, in response to the introduction of the Therapeutic Allergen Regulation (TAV).
Subscribe to our email newsletter
To date many products have been available in Germany on a ‘named patient’ basis, however, as a result of the TAV all immunotherapy products containing common allergens (grass, trees, house dust mites and insect venoms) will need marketing authorisations by 2017.
Since 2008, Allergy Therapeutics has reviewed its product portfolio and has been preparing MAAs for its top 10 products in the Pollinex Quattro, Tyrosin TU t.o.p. and Oralvac Compact ranges.
Allergy Therapeutics CEO Manuel Llobet said the regulatory landscape in Germany, the largest immunotherapy market in Europe, has been undergoing a significant period of change.
"Our response has been a crucial project for Allergy Therapeutics and its completion is a major achievement. The regulatory changes should favour the company as the market will become focused on evidence-based, approved, value-added immunotherapy products and the company is well-placed to deliver a range of such products," Llobet said.